Use Of Rapid Deployment Valves Research Articles

Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial

BackgroundThe use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory–adjudicated data are scarce, however. Here we report final 7-year data on RDV use. MethodsTRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory–adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 ± 2.0 years. ResultsThe mean patient age was 73.3 ± 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 ± 5.3 mm Hg and 1.6 ± 0.3 cm2, respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. ConclusionsAVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

Implante de la prótesis Edwards Intuity Elite en cirugía plurivalvular y en cirugía de revascularización coronaria concomitante

IntroductionConcomitant use of rapid deployment valves is not widespread. A EDWARDS INTUITY Elite valve replacement and concomitant mitral valve replacementent or coronary artery bypass grafting (CABG) were performed. Patients and methodsWe implanted 15 consecutive EDWARDS INTUITY Elite in patients with mitral valve replacement or concomitant CABG. Patients were divided in two groups: Intuity + mitral (8 patients), and Intuity + CC (7 patients). We registered aortic cross-clamp and cardio-pulmonary bypass (CPB) times, and ICU and Hospital length of stay. Two control groups were selected: control + mitral (43 consecutive patients submitted to multiple valve surgery) and control + CC group (48 consecutive patients with aortic replacement and concomitant CABG). Mean and peak intra-prosthesis gradients were calculated before discharge by means trans-thoracic echocardiogram. ResultsThere were no intraoperative complications. Cross-clamp times in Intuity + mitral and Intuity + CC groups were 84,3 ± 10,1 and 67,1 ± 20,7, significantly lower than control groups (117 ± 36,1 y 102,7 ± 27,3) respectively. CPB times in Intuity + mitral were 112 ± 11,6 significantly lower than control group (138,1 ± 43,7). No paravalvular leaks or prosthesis dysfunction were observed. Two patients death during the follow-up. ConclusionsEDWARDS INTUITY Elite prosthesis significantly reduces CPB and cross clamp time when used in multiple valve surgery and cross clamp time in patients with concomitant CABG. The implantation is safe and feasible, and the postoperative intra-prosthetic gradients are adequate.

Use of an Aortic Valve Replacement Simulation Model to Understand Hospital Costs and Resource Utilization Associated With Rapid-deployment Valves

PurposeAortic stenosis (AS) is the most common cause of adult valvular heart disease. In the past decade, minimally invasive surgery (MIS) to treat AS has gained popularity, especially if performed in combination with rapid deployment valves (RDVs), which shorten cross-clamp time (XCT). This study examines specific outcomes and related costs of aortic valve replacement (AVR) before and after the introduction of RDVs. MethodsWe used the AVR simulator, an economic model developed to correlate cost and resource utilization associated with the adoption of RDVs, to compare 2 scenarios: (1) a current scenario based on standard AVR practices and (2) a proposed scenario based on increasing use of RDVs and an MIS approach. Both scenarios involved 3 subgroups of patients treated with (1) conventional AVR, (2) MIS, and (3) AVR combined with a coronary artery bypass graft. The current scenario (status quo) involved patients treated with traditional biological valves, and the proposed scenario involved patients who underwent implantation with an RDV. The AVR simulator was fed with real-world input data to estimate complication rates and resource consumption in the proposed scenario. Real-world input data for this analysis were obtained from patients diagnosed with a symptomatic heart valve disease between 2015 and 2018, at Clinica-San-Gaudenzio, Novara, Italy. Lastly, the AVR simulator estimated hospital savings by comparing the 2 scenarios. FindingsA total of 132 patients underwent implantation with a traditional biological valve, and 107 were treated with a commercial valve system. The RDV was associated with an increase of 52% of patients undergoing MIS, which generated a 6.1-h reduction of XCT and a total savings of €6695. RDVs also reduced intensive care unit (ICU) and hospital ward length of stay (LOS), leading to savings of €677 and €595 per patient, respectively. Mortality and blood transfusions also improved. The savings for the hospital (related to shorter XCT, hospital ward LOS, and ICU LOS) amounted to €144.111. Our findings were consistent with data gathered from our real-word setting, and results of a sensitivity analysis indicate that our findings were robust across different possible situations. ImplicationsSwitching to RDVs and MIS procedures for AVRs was associated with a reduction of costs related to XCT, hospital ward LOS, and ICU LOS. Hospitals can upload literature- and experience-based clinical and cost values to the AVR simulator to estimate a hospital's performance with the introduction of RDVs compared with standard biological valves. This study was not randomized, so more extensive studies could confirm our results in the future.

The Use of Rapid Deployment Valves in Combined Aortic and Mitral Valve Surgery: One-Year Clinical and Echocardiographic Outcomes.

Patients undergoing multiple valve surgery represent a high-risk group who could potentially benefit from a reduction of cross-clamp and cardiopulmonary bypass times because prolonged bypass and cross-clamp times are considered independent risk factors for increased morbidity and mortality after cardiac surgery. Between July 2013 and November 2014, 16 patients underwent rapid deployment aortic valve replacement with the EDWARDS INTUITY valve system in the setting of concomitant mitral disease. Fifteen patients showed mitral regurgitation, whereas one patient had severe mitral stenosis. Fourteen patients received mitral valve repair and two patients received biological mitral valve replacement. Tricuspid valve repair was performed additionally in two patients. The mean ± SD age was 72.8 ± 8.4 years, and the mean ± SD logistic EuroSCORE II is 8.7% ± 3.4%. Within a 30-day perioperative period, no patient was lost (n = 0). The mean ± SD follow-up time was 11 ± 2 months. At 1 year, the overall survival was 81% (n = 13). A mean ± SD transaortic gradient of 10.7 ± 2.3 mm Hg and a mean ± SD effective orifice area of 1.7 ± 0.3 cm were measured echocardiographically. No higher-grade paravalvular leak (aortic insufficiency > 1+) occurred. Eight patients (61%) had no residual mitral regurgitation, four patients (30%) showed trivial regurgitation (1/4), and one patient (7.3%) had moderate mitral regurgitation (2/4). No interference of the subannular stent frame with the reconstructed valve or the biological mitral prosthesis was seen. Rapid deployment aortic valve replacement with the EDWARDS INTUITY valve system in combined aortic and mitral valve surgery can be performed safely with reproducible results. One-year follow-up data of this small series shows encouraging results potentially justifying the extension of the indication for rapid deployment valves to patients with concomitant mitral disease. Especially elderly patients undergoing multiple valve surgery may benefit from a reduction of cardiopulmonary bypass and myocardial ischemic times.

The Use of Rapid Deployment Valves in Combined Aortic and Mitral Valve Surgery

The Use of Rapid Deployment Valves in Combined Aortic and Mitral Valve Surgery

Mini-aortic surgery with percutaneous cannulation and rapid-deployment valve.

We aimed to evaluate the results of the combined use of rapid-deployment valves, percutaneous cardioplegia delivery and left heart venting during minimally invasive aortic valve replacement surgery. We identified 2 propensity-matched cohorts of patients who underwent primary elective isolated minimally invasive aortic valve surgery at our center over a 3-years period: 30 patients in group A had a conventional valve prosthesis and 30 patients in group B received a rapid-deployment valve using percutaneous cardioplegia delivery and percutaneous left heart venting. Skin incision length, intraoperative times, postoperative hospital outcomes, and 30-day echocardiographic results were compared between the 2 groups. Patients in group B had significantly shorter operative times and shorter skin incisions compared to group A (total operative time 196.0 ± 40.6 vs. 225.1 ± 30.8 min, respectively, p < 0.003; cardiopulmonary bypass time 79.9 ± 10.6 vs. 92.9 ± 17.2 min respectively, p < 0.001; crossclamp time 52.3 ± 9.6 vs. 74.9 ± 10.2 min, respectively, p < 0.001; incision length 3.6 ± 0.5 vs. 6.0 ± 0.6 cm, respectively, p < 0.001). Postoperative hospital outcomes and echocardiographic evaluation showed no significant differences. The combined use of rapid-deployment valves, percutaneous cardioplegia, and left heart venting is safe and effective and allows a significant reduction of the skin incision together with a significant reduction of intraoperative times without affecting hospital outcomes or hemodynamic performance of the prosthetic valves.

Invited Commentary

Rapid deployment and sutureless valves are being implanted with increasing frequency—particularly in Europe—but specific patient populations for these devices remain to be defined. Theron and colleagues [1Theron A. Gariboldi V. Grisoli D. et al.Rapid deployment of aortic bioprosthesis in elderly patients with small aortic annulus.Ann Thorac Surg. 2016; 101: 1434-1442Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar] have focused on the use of rapid deployment valves in a clinically important subgroup of patients in this issue of The Annals, namely, elderly patients with a small aortic annulus. Severe aortic stenosis is often accompanied by fibrosis and calcification of the aortic root in elderly patients, resulting in an inability to insert an adequately sized prosthesis. Simple implantation of a hemodynamically superior valve would be preferable to annular enlargement procedures in elderly patients. Aortic annular enlargement is associated with prolonged aortic cross-clamp and cardiopulmonary bypass times [2Kulik A. Al-Saigh M. Chan V. et al.Enlargement of the small aortic root during aortic valve replacement: is there a benefit?.Ann Thorac Surg. 2008; 85: 94-100Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar] and can be particularly challenging in patients with a calcified aortic root. Previous studies have demonstrated excellent hemodynamic performance for rapid deployment and sutureless valves [3Folliguet T.A. Laborde F. Zannis K. et al.Sutureless Perceval aortic valve replacement: results of two European centers.Ann Thorac Surg. 2012; 93: 1483-1488Abstract Full Text Full Text PDF PubMed Scopus (173) Google Scholar, 4Borger M.A. Moustafine V. Conradi L. et al.A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement.Ann Thorac Surg. 2015; 99: 17-25Abstract Full Text Full Text PDF PubMed Scopus (150) Google Scholar]. Furthermore, a recent randomized clinical trial demonstrated significant reductions in early transvalvular gradients and prevalence of patient-prosthesis mismatch—despite a relatively small sample size—in patients receiving a rapid deployment valve compared with similarly sized conventional bioprostheses [4Borger M.A. Moustafine V. Conradi L. et al.A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement.Ann Thorac Surg. 2015; 99: 17-25Abstract Full Text Full Text PDF PubMed Scopus (150) Google Scholar]. The hemodynamic benefits of these devices, combined with their rapid implantation times and subsequent reduction in myocardial ischemia [3Folliguet T.A. Laborde F. Zannis K. et al.Sutureless Perceval aortic valve replacement: results of two European centers.Ann Thorac Surg. 2012; 93: 1483-1488Abstract Full Text Full Text PDF PubMed Scopus (173) Google Scholar, 4Borger M.A. Moustafine V. Conradi L. et al.A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement.Ann Thorac Surg. 2015; 99: 17-25Abstract Full Text Full Text PDF PubMed Scopus (150) Google Scholar, 5Schlomicher M. Haldenwang P.L. Moustafine V. Bechtel M. Strauch J.T. Minimal access rapid deployment aortic valve replacement: initial single-center experience and 12-month outcomes.J Thorac Cardiovasc Surg. 2015; 149: 434-440Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar], may make them an ideal option in elderly patients with a small aortic annulus. In addition, rapid deployment valves appear to facilitate minimally invasive operations. Minimally invasive rapid deployment valve implantation may represent an effective and financially attractive alternative to transcatheter aortic valve replacement procedures in medium-risk elderly patients. One may expect lower paravalvular leak rates and possibly decreased pacemaker implantation requirements compared with transcatheter aortic valve replacement. Results of two large, nearly completed U.S. Food and Drug Administration approval trials will hopefully shed more light on the use of these devices in elderly patients with small aortic annuli and whether they represent a good alternative to transcatheter aortic valve replacement in this patient population. Rapid Deployment of Aortic Bioprosthesis in Elderly Patients With Small Aortic AnnulusThe Annals of Thoracic SurgeryVol. 101Issue 4PreviewAortic valve replacement in elderly patients with a small aortic annulus remains challenging. Patient–prosthesis mismatch (PPM) should be prevented without impacting operative mortality. Hemodynamic benefits resulting from rapid-deployment aortic valve replacement with the Edwards Intuity bioprosthesis for this indication were evaluated. Full-Text PDF